仙琚製藥(002332.SZ):屈螺酮炔雌醇片(Ⅱ)境內生產藥品註冊申請獲受理
格隆匯5月12日丨仙琚製藥(002332.SZ)宣佈,公司於近日收到國家藥品監督管理局下發的屈螺酮炔雌醇片(Ⅱ)境內生產藥品註冊受理通知書。
屈螺酮炔雌醇片(Ⅱ)為複方製劑,包含屈螺酮和炔雌醇兩種活性成分。產品規格為炔雌醇0.020mg和屈螺酮3.000mg。參比製劑為國內上市的進口原研產品屈螺酮炔雌醇片(Ⅱ)(商品名:優思悦®)。該參比製劑由德國拜耳開發,2006年3月通過FDA批准上市,又於2008年7月16日在德國上市。2014年12月,優思悦®在中國獲批進口,目前在仿製藥參比製劑目錄第八批被推薦為參比製劑。
適應症:1.女性口服避孕藥。2.中度尋常痤瘡,適用於≥14歲、沒有口服避孕藥已知禁忌的已初潮女性。只有在患者希望使用口服避孕藥作為避孕措施時才能使用該藥品治療痤瘡。
該次公司申報的屈螺酮炔雌醇片(Ⅱ)規格與原研已批准上市的規格一致,按化學藥品4類進行申報。
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